Support You Could Use

†Results of a nationwide study published in 2015 by the Journal of the American Medical Association.

For any questions about Brisdelle

Call: 888-246-1207

For any questions about Brisdelle

Call: 888-246-1207

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about BRISDELLE?

Call your healthcare provider right away if you have any of the following symptoms,
or go to the nearest emergency room:

Suicidal thoughts or actions:

BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts
or actions within the first few months of treatment.

Depression or other serious mental illnesses are the most important causes of
suicidal thoughts or actions.

Watch for these changes and call your healthcare provider right away if you notice:

New or sudden changes in mood, behavior, actions, thoughts, or feelings,
especially if severe.

Pay particular attention to such changes when BRISDELLE is started.

Keep all follow-up visits with your healthcare provider and call between visits if you
are worried about symptoms.

Call your healthcare provider right away or go to the nearest emergency room if you
have any of the following symptoms, especially if they are new, worse, or worry you:

Attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent;
thoughts about suicide or dying; new or worse depression; new or worse anxiety or panic
attacks; feeling agitated, restless, angry, or irritable; trouble sleeping; an increase in
activity or talking more than what is normal for you or other unusual changes in behavior
or mood.

Serotonin Syndrome. This condition can be life-threatening and may include:
Nervousness, hallucinations, coma, or other changes in mental status; coordination
problems or small movements of the muscles that you cannot control; racing heartbeat,
high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle
rigidity; dizziness; flushing; tremors; seizures.

Reduced effectiveness of tamoxifen: Tamoxifen (a medicine used to treat breast cancer)
may not work as well if it is taken at the same time as BRISDELLE. If you are taking
tamoxifen, tell your healthcare provider before starting BRISDELLE.

Abnormal bleeding: BRISDELLE may increase your risk of bleeding or bruising,
especially if you take the blood thinner warfarin, or non-steroidal anti-inflammatory drugs
(NSAIDs), like ibuprofen, naproxen, or aspirin.

Visual symptoms.

Low salt (sodium) levels in the blood: Elderly people may be at greater risk for this.
Symptoms may include: headache; weakness or feeling unsteady; confusion, problems
concentrating or thinking or memory problems.

Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.

Take thioridazine or pimozide. Do not take thioridazine or pimozide together with
BRISDELLE because this can cause serious heart problems or sudden death.

Are allergic to paroxetine or any of the ingredients in BRISDELLE.

Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn
baby.

What should I tell my healthcare provider before starting BRISDELLE?

Before starting BRISDELLE, tell your healthcare provider if you:

Have liver or kidney problems; bipolar disorder or mania; low sodium levels in your blood;
glaucoma (high pressure in the eye); have or had seizures, convulsions, or bleeding
problems; have any other medical conditions; are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines that you take, including
prescription and non-prescription medicines such as migraine headache medication
(triptans), other antidepressants and antipsychotics, vitamins, and herbal supplements.

If you take BRISDELLE, you should not take any other medicines that contain paroxetine,
including Paxil®, Paxil CR®, and Pexeva®.

What should I avoid while taking BRISDELLE?

You should not drive, operate heavy machinery, or do other dangerous activities until you
know how BRISDELLE affects you.

What are the most common side effects of BRISDELLE?

The most common possible side effects of BRISDELLE include: headache; tiredness;
nausea and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or does not go
away. These are not all the possible side effects of BRISDELLE.

INDICATION

BRISDELLE® (paroxetine) capsules is a prescription medicine used to reduce moderate to
severe hot flashes associated with menopause.

BRISDELLE is not approved to treat depression or any other psychiatric conditions.

Please read the Medication Guide within the full Prescribing Information before taking BRISDELLE. Call your doctor for
medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.

Brisdelle® and Pexeva® are registered trademarks of Sebela International Ltd.
All other registered trademarks are the property of their respective owners.

Brisdelle®, the Brisdelle Logo, the 3 Wings Design, and My Brisdelle® are registered trademarks of Sebela International Ltd.
All other registered trademarks are the property of their respective owners.

Important Safety Information

What is the most important information I should know about BRISDELLE (paroxetine)?

Call your healthcare provider right away if you have any of the following symptoms,
or go to the nearest emergency room:

Suicidal thoughts or actions:

BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts
or actions within the first few months of treatment.

Depression or other serious mental illnesses are the most important causes of
suicidal thoughts or actions.

Watch for these changes and call your healthcare provider right away if you notice:

New or sudden changes in mood, behavior, actions, thoughts, or feelings,
especially if severe.

Pay particular attention to such changes when BRISDELLE is started.

Keep all follow-up visits with your healthcare provider and call between visits if you
are worried about symptoms.

Call your healthcare provider right away or go to the nearest emergency room if you
have any of the following symptoms, especially if they are new, worse, or worry you:

Attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent;
thoughts about suicide or dying; new or worse depression; new or worse anxiety or panic
attacks; feeling agitated, restless, angry, or irritable; trouble sleeping; an increase in
activity or talking more than what is normal for you or other unusual changes in behavior
or mood.

Serotonin Syndrome. This condition can be life-threatening and may include:
Nervousness, hallucinations, coma, or other changes in mental status; coordination
problems or small movements of the muscles that you cannot control; racing heartbeat,
high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle
rigidity; dizziness; flushing; tremors; seizures.

Reduced effectiveness of tamoxifen: Tamoxifen (a medicine used to treat breast cancer)
may not work as well if it is taken at the same time as BRISDELLE. If you are taking
tamoxifen, tell your healthcare provider before starting BRISDELLE.

Abnormal bleeding: BRISDELLE may increase your risk of bleeding or bruising,
especially if you take the blood thinner warfarin, or non-steroidal anti-inflammatory drugs
(NSAIDs), like ibuprofen, naproxen, or aspirin.

Visual symptoms.

Low salt (sodium) levels in the blood: Elderly people may be at greater risk for this.
Symptoms may include: headache; weakness or feeling unsteady; confusion, problems
concentrating or thinking or memory problems.

Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.

Take thioridazine or pimozide. Do not take thioridazine or pimozide together with
BRISDELLE because this can cause serious heart problems or sudden death.

Are allergic to paroxetine or any of the ingredients in BRISDELLE.

Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn
baby.

What should I tell my healthcare provider before starting BRISDELLE?

Before starting BRISDELLE, tell your healthcare provider if you:

Have liver or kidney problems; bipolar disorder or mania; low sodium levels in your blood;
glaucoma (high pressure in the eye); have or had seizures, convulsions, or bleeding
problems; have any other medical conditions; are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines that you take, including
prescription and non-prescription medicines such as migraine headache medication
(triptans), other antidepressants and antipsychotics, vitamins, and herbal supplements.

If you take BRISDELLE, you should not take any other medicines that contain paroxetine,
including Paxil®, Paxil CR®, and Pexeva®.

What should I avoid while taking BRISDELLE?

You should not drive, operate heavy machinery, or do other dangerous activities until you
know how BRISDELLE affects you.

What are the most common side effects of BRISDELLE?

The most common possible side effects of BRISDELLE include: headache; tiredness;
nausea and vomiting.

Tell your healthcare provider if you have any side effect that bothers you or does not go
away. These are not all the possible side effects of BRISDELLE.

INDICATION

BRISDELLE® (paroxetine) capsules is a prescription medicine used to reduce moderate to
severe hot flashes associated with menopause.

BRISDELLE is not approved to treat depression or any other psychiatric conditions.

Please read the Medication Guide within the full Prescribing Information before taking BRISDELLE. Call your doctor for
medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to the FDA. Visit
http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Brisdelle® and Pexeva® are registered trademarks of Sebela International Ltd.
All other registered trademarks are the property of their respective owners.

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